Cameron Health Gets CE Mark for Subcutaneous Lead ICD

 

June 16, 2009

June 16, 2009 - Cameron Health Inc. said today it received CE approval for its Cameron Subcutaneous Implantable Defibrillator (S-ICD) system.

The minimally invasive S-ICD is prescribed for use in patients at risk of sudden cardiac arrest (SCA). The system is unique in that the implantation of the system is entirely subcutaneous - no leads are placed in or on the heart. Additionally, no imaging equipment is required for placement of the S-ICD, as all of the components may be positioned using anatomical landmarks, the company said.

Conventional ICD’s require placement of at least one lead in or on the heart. Most frequently, these leads, constructed of thin insulated wires, are threaded through a vein and then placed inside the heart. These conventional transvenous leads allow for sensing of the heart’s rhythm and delivery of a life saving electric shock when a harmful arrhythmia is detected. The surgical placement and residence of these transvenous leads within the patient’s heart are associated with a significant proportion of the complications related to this well-established and highly effective therapy, the company said. In contrast, the Cameron Health S-ICD system resides just under the skin, potentially avoiding many of the complications associated with the conventional implant procedure and long-term performance. The S-ICD system is also designed for ease of placement and removal while shortening the surgical procedure time. The company said the S-ICD is the first totally subcutaneous implantable defibrillator used to treat SCA. Market launch is scheduled to commence this summer in select geographies as Cameron Health ramps production.

Components of the Cameron Health S-ICD system include the SQ-RX Pulse Generator, Q-TRAK Subcutaneous Electrode, Q-GUIDE Electrode Insertion Tool and the Q-TECH Programmer. The S-ICD system is implanted subcutaneously (just under the skin) with the electrode running parallel and slightly to the left of the sternum. While most functions are automatic, adjustments and data retrieval can be easily achieved through an advanced, integrated programming system developed specifically for the S-ICD system, the company said. The Q-TECH Programmer is one of the smallest units in the industry, weighing less than 3 pounds. The lightweight, portable unit is capable of wireless communication with the SQ-RX Pulse Generator.

For more information: www.cameronhealth.com